HIV is a major health problem worldwide especially in low-to middle-income countries
including Thailand. Fortunately, a significant reduction in morbidity and mortality has been
observed due to the use of combination antiretroviral therapy. As the natural history of the
disease is modified, non-communicable diseases are becoming recognized complications of HIV
infection, including insulin resistance, dyslipidemia and type 2 diabetes. The prevalence of
type 2 diabetes in HIV-infected patients is significantly higher than in the general
population, likely contributed by antiretroviral regimen and an ongoing, usually subclinical,
inflammation. People with prediabetes, a condition which blood sugars are elevated but not
yet meeting the criteria for diabetes, represent a high risk group for future diabetes
development. Lifestyle interventions, including diet and exercise, are effective in reducing
the future diabetes risk by as much as 58%, including in Thailand. The knowledge whether
these interventions are effective in HIV-infected patients, given their unique
characteristics, is not available at this time but urgently needed. Moreover, the program
tailored to each country's local values, culture and socioeconomic status is essential as
participants' acceptability is one of the keys to program's success. This current proposal
will adapt a 6-month intensive lifestyle intervention program and evaluate its feasibility
and acceptability in HIV-infected individuals with prediabetes in Thailand. The knowledge
gained will be highly relevant for Thailand and for other low-to-middle-income countries.
Furthermore, gut microbiota and insufficient sleep are novel factors shown to affect
individual's metabolic health. Insufficient sleep is recognized as a risk factor for incident
diabetes. Gut microbiota composition differs between those with and without diabetes. The
current proposal will examine how gut microbiota and sleep duration differ between
HIV-infected individuals with and without prediabetes, and now there change or modulate the
metabolic response to the 6-month intensive lifestyle interventions. Lastly, HIV and diabetes
are global epidemics, research capacity building among countries is essential to battle these
health problems. This proposal will aim to build research capacities among three
international institutions: University of Illinois at Chicago, Illinois, U.S.A.; Faculty of
Medicine Ramathibodi Hospital, Mahidol University, Thailand, one of the top medical schools
in Thailand; and a newly formed medical school, Navamindradhiraj University, Vajira Hospital,
Bangkok, Thailand. Through close collaboration, networking, in-person training and workshops,
the proposed study will enhance research capacity and improve lives of those living with HIV.

Background:
- Insulin receptor mutation causes high blood sugars and sometimes diabetes complications.
Researchers want to see if thyroid hormone helps.
Objectives:
- To see if thyroid hormone treatment changes how the body handles sugar in people with
insulin receptor mutation and improves blood sugar in people with diabetes.
Eligibility:
- People ages 12 65 with an insulin receptor mutation.
Design:
- Study part 1:19-day clinic stay. Participants will be monitored for 4 days. Then for 15
days they will take a thyroid hormone pill 3 times a day. Participants will have:
- Blood tests.
- Heart rate and skin temperature monitored.
- All their food provided.
- Two 5-hour sessions in a special room. They will wear special clothes and sometimes sit
still.
- Two small tubes inserted in veins. One will deliver tiny amounts of sugar and fat with a
non-radioactive tracer. Participants will also drink water with a tracer. The other tube
will collect blood.
- A sweet drink. Participants may have finger stick blood sugar tests.
- Glucose-monitoring device inserted into body fat for two 24-hour periods.
- Adults may have samples of fat and muscle taken.
- Heart ultrasound.
- PET-CT scan in a machine. An intravenous catheter will be placed in an arm vein. A small
amount of radioactive substance will be injected.
- DEXA scan of body fat and bone density.
- Participants with poorly controlled diabetes will then take thyroid hormone at home for
6 months. They will have blood drawn and sent to the study team monthly.
- After about 3 months, they will have an overnight visit. After 6 months, they will have
a 4-day visit.

Background:
- Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in
minority populations. Few drug treatments are approved for T2DM in adolescents, and
behavioral and lifestyle factors may contribute to their difficulties in following
strict treatment regimens.
- It is unknown whether a minimally invasive patient partner ( buddy ) program, which has
been developed to help improve diabetes control and quality of life, will be successful
in a population of pediatric patients with T2DM.
Objectives:
- To evaluate the effect of a minimally invasive intervention (being assigned a patient
partner, or buddy ) on blood sugar levels in adolescents with T2DM.
- To assess changes between groups in body weight, number of home glucose monitor checks,
compliance with medications, adherence to visit schedule, and psychological well-being.
Eligibility:
- Adolescents and young adults between 12 and 20 years of age who have been diagnosed with
type 2 diabetes and whose blood glucose control needs improvement.
Design:
- Participants will be divided by chance into two groups: in one group, participants will
have a buddy and receive standard care; while in the other group, participants will
receive standard care alone.
- The buddy is not a health care professional and is not authorized to provide any medical
advice.
- Participants will be followed in the study for a total of 6 months. All study
participants will receive standard treatment for T2DM.
- All patients will be asked to fill out a screening questionnaire (on paper or online) at
the beginning of the study and a quality of life and eating behaviors questionnaire at
the beginning and at the end of the study. These forms will include questions on medical
history, emotions, well-being, and eating habits.
- Participants in both groups will have one diabetes clinic visit at the NIH Clinical
Center or at Children s National Medical Center (CNMC) at the beginning of the study and
two follow-up visits at the NIH or CNMC approximately 3 months apart. All visits include
a physical examination, detailed medical history, and laboratory testing which is part
of routine care for diabetes.
- Participants assigned to the buddy group will receive phone or online messages from the
buddy once a week and will meet with the buddy once a month for less than 1 hour. The
purpose of the in-person visit is to get to know each other better outside the usual
hospital or clinic environment. The visits should take place at home, but may also take
place elsewhere, for example, at schools, cafes, or libraries chosen by both the
participant and the buddy. These face-to-face meetings may also take place at NIH or at
CNMC if this is more convenient.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The data & information found on this website is provided “AS IS” from ClinicalTrials.gov.
Neither we, the United States Government, U.S. Department of Health and Human Services, National Institutes of Health, National Library of Medicine, nor any of its agencies, contractors, subcontractors or employees of the United States Government make any warranties, expressed or implied, with respect to data found on this site, and, furthermore, assume no liability, or the results of such use, of any part of the data.